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10月30日,国家药品监督管理局(SDA)局长郑筱萸签署第35号局令《药品注册管理办法》(试行)。该办法于2002年10月15日经SDA局务会审议通过,于2002年12月1日起施行(转摘总则、附件四的部分内容)。 该办法共分18章,208条。SDA于1999年4月22日颁布的《新药审批办法》(局令第2号)、《新生物制品审批办法》(局令第3号)、《新药保护和技术转让的规定》(局令第4号)、《仿制药品
On October 30, Zheng Xiaoyu, director of the State Drug Administration (SDA), signed Order No. 35 (Measures for the Administration of Drug Registration (for Trial Implementation. This measure was approved by the SDA Bureau on October 15, 2002 and came into force on December 1, 2002 (General Provisions for Transfer and Part of Annex IV). The method is divided into 18 chapters and 208 articles. The Measures for the Examination and Approval of New Drugs (Decree No. 2), the Measures for the Approval of New Biological Products (Decree No. 3), the Provisions for the Protection of New Drugs and Technologies for Transfer (Order No. 4), "generic drugs